MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P980016/S003 · decided 1999-07-27
Approval details
- PMA number
- P980016
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-02-05
- Decision date
- 1999-07-27
- Days to decision
- 172 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Model 7229 (GEM(TM) II VR) Implantable Cardioverter Defibrillator and Model 9964 Application Software and the quality assurance test method and specification for screening the GEM(TM) II VR for premature battery depletion, and the revised L222 integrated circuit.
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